Product Testing; Noncompliance. 8.8.1. After Manufacturer’s Release. After Manufacturer’s Release of the Merck Compound and concurrently with Delivery of the Compound to Company, Merck shall provide Company with such certificates and documentation as are described in the Clinical Quality Agreement (“Disposition Package”). Company shall, within the time defined in the Clinical Quality Agreement, perform, with respect to the Merck Compound, the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement. Company shall be solely responsible for taking all steps necessary to determine that Merck Compound or Company Compound, as applicable, is suitable for release before making such Merck Compound or Company Compound, as applicable, available for human use, and Merck shall provide cooperation or assistance as reasonably requested by Company in connection with such determination with respect to the Merck Compound. Company shall be responsible for storage and maintenance of the Merck Compound until it is tested and/or released, which storage and maintenance shall be in compliance with (a) the Specifications for the Merck Compound, the Clinical Quality Agreement and Applicable Law and (b) any specific storage and maintenance requirements as may be provided by Merck from time to time. Company shall be responsible for any failure of the Merck Compound to meet the Specifications to the extent caused by shipping, storage or handling conditions after Delivery to Company hereunder.
Appears in 2 contracts
Samples: Collaboration and Supply Agreement (IMMUTEP LTD), Clinical Trial Collaboration and Supply Agreement (ONCOSEC MEDICAL Inc)
Product Testing; Noncompliance. 8.8.1. After Manufacturer’s Release. After Manufacturer’s Release of the Merck Company Compound and concurrently with Delivery of the Compound to CompanyMerck, Merck Company shall provide Company Merck with such certificates and documentation as are described in the Clinical Quality Agreement (“Disposition Package”). Company Merck shall, within the time defined in the Clinical Quality Agreement, perform, perform with respect to the Merck Company Compound, the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement. Company Merck shall be solely responsible for taking all steps necessary to determine that Merck Compound or Company Compound, as applicable, is suitable for release before making such Merck Compound or Company Compound, as applicable, available for human use, and Merck Company shall provide cooperation or assistance as reasonably requested by Company Merck in connection with such determination with respect to the Merck Company Compound. Company Merck shall be responsible for storage and maintenance of the Merck Company Compound until it is tested and/or released, which storage and maintenance shall be in compliance with (a) the Specifications for the Merck Company Compound, the Clinical Quality Agreement and Applicable Law and (b) any specific storage and maintenance requirements as may be provided by Merck Company from time to time. Company Merck shall be responsible for any failure of the Merck Company Compound to meet the Specifications to the extent caused by shipping, storage storage, handling or handling other conditions or circumstances after Delivery to Company Merck hereunder.
Appears in 1 contract
Samples: Trial Collaboration and Supply Agreement (Array Biopharma Inc)
Product Testing; Noncompliance. 8.8.1. 8.8.1 After Manufacturer’s Release. After Manufacturer’s Release of the Merck Compound and concurrently with Delivery of the Compound to Company, Merck shall provide Company with such certificates and documentation as are described in the Clinical Quality Agreement (“Disposition Package”). Company shall, within the time defined in the Clinical Quality Agreement, perform, with respect to the Merck Compound, the acceptance (including testing) procedures allocated to it under the Clinical Quality Agreement. Company shall be solely responsible for taking all steps necessary to determine that Merck Compound or Company Compound, as applicable, is suitable for release before making such Merck Compound or Company Compound, as applicable, available for human use, and Merck shall provide cooperation or assistance as reasonably requested by Company in connection with such determination with respect to the Merck Compound. Company shall be responsible for storage and maintenance of the Merck Compound until it is tested and/or released, which storage and maintenance shall be in compliance with (a) the Specifications for the Merck Compound, the Clinical Quality Agreement and Applicable Law and (b) any specific storage and maintenance requirements as may be provided by Merck from time to time. Company shall be responsible for any failure of the Merck Compound to meet the Specifications to the extent caused by shipping, storage or handling conditions after Delivery to Company hereunder.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (ONCOSEC MEDICAL Inc)